Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01135589

Collaborator

Astellas Pharma Korea, Inc. (Industry)

145

Enrollment

Locations

Arm

Duration (Months)

20.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

Condition or Disease	Intervention/Treatment	Phase
Neutropenia Hematopoietic Stem Cell Transplantation Invasive Fungal Disease	Drug: Micafungin	Phase 4

Detailed Description

The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

145 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

May 1, 2012

Anticipated Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HSCT	Drug: Micafungin i.v. Other Names: FK463 Fungard

Arm

Intervention/Treatment

Experimental: HSCT

Drug: Micafungin

i.v.

Other Names:

FK463

Fungard

Outcome Measures

Primary Outcome Measures

Absence rate of IFDs assessed by physical examination and serum galactomannan test [during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis]

Secondary Outcome Measures

Survival rate [at day 100]
Safety assessed by lab-test and adverse events [during micafungin prophylaxis therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients will receive allogeneic hematopoietic stem cell transplantation

Exclusion Criteria:

Aspartate transaminase or alanine transaminase level > 5 times UNL
Bilirubin > 2. 5 times UNL
History of allergy, sensitivity, or any serious reaction to an echinocandin
Invasive fungal disease at the time of enrolment
Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
Positive pregnancy test

Contacts and Locations

Locations

	City	Country
1	Busan	Korea, Republic of
2	Daegu	Korea, Republic of
3	Daejeon	Korea, Republic of
4	Goyang	Korea, Republic of
5	Hwasun	Korea, Republic of
6	Seoul	Korea, Republic of
7	Suwon	Korea, Republic of